FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
9265–9288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2023
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
K231011 · HQF
Meridian AG
Ophthalmic · 155d
Cleared Sep 12, 2023
Stone Extraction Baskets
K230598 · LQR
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 193d
Cleared Sep 12, 2023
Ablation-fit
K222938 · QTZ
R.A.W. S.R.L
Radiology · 351d
Cleared Sep 12, 2023
Endure ETCO2/02 Nasal Cannula
K213767 · CCK
Endure Industries, Inc.
Anesthesiology · 650d
Cleared Sep 11, 2023
Venus Versa PRO System
K232192 · ONF
Venus Concept, Inc.
General & Plastic Surgery · 49d
Cleared Sep 11, 2023
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
K232154 · OVD
MiRus, LLC
Orthopedic · 53d
Cleared Sep 11, 2023
Vantage® Total Ankle System
K232002 · HSN
Exactech, Inc.
Orthopedic · 68d
Cleared Sep 11, 2023
VERIFY Spore Test Strip for S40 Sterilant Concentrate
K231746 · OVY
STERIS Corporation
General Hospital · 88d
Cleared Sep 11, 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
K231504 · HWC
Vilex, LLC
Orthopedic · 110d
Cleared Sep 11, 2023
SiteRite™ 9 Ultrasound System
K231283 · IYO
Bard Access Systems, Inc. (C.R. Bard,...
Radiology · 131d
Cleared Sep 11, 2023
Change Healthcare Cardiology Hemodynamics™
K230881 · MWI
Change Healthcare Israel , Ltd.
Cardiovascular · 165d
Cleared Sep 11, 2023
Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture...
K230517 · MBI
Jarmon Medical, LLC (Dba Legends...
Orthopedic · 196d
Cleared Sep 11, 2023
Planar LED mate
K230362 · OHT
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 213d
Cleared Sep 11, 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · CGA
Abbott Point of Care, Inc.
Chemistry · 270d
Cleared Sep 09, 2023
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software...
K223864 · HAW
Brainlab AG
Neurology · 260d
Cleared Sep 08, 2023
CorVista® System
K232686 · QXX
Corvista Health, Inc.
Cardiovascular · 7d
Cleared Sep 08, 2023
Q-FIX ULTRA All-Suture Anchor
K232457 · MBI
Smith & Nephew
Orthopedic · 25d
Cleared Sep 08, 2023
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS)...
K232426 · MBH
Conformis, Inc.
Orthopedic · 28d
Cleared Sep 08, 2023
Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
K232414 · JWH
Total Joint Othopedics, Inc.
Orthopedic · 29d
Cleared Sep 08, 2023
Fusion Robotic Navigation System
K232413 · OLO
Alphatec Spine, Inc.
Orthopedic · 29d
Cleared Sep 08, 2023
VariSeed (v10)
K232400 · MUJ
Varian Medical Systems
Radiology · 29d
Cleared Sep 08, 2023
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with...
K232386 · NQQ
Abbott Medical
Cardiovascular · 30d
Cleared Sep 08, 2023
PreXion3D Expedition
K232166 · OAS
Prexion Corporation
Radiology · 49d
Cleared Sep 08, 2023
Sterile syringes for single use with/without needle
K231729 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d